India

Indian Draft Chemicals (Management and Safety) Rules

Little Pro on 2020-12-16

Indian Draft Chemicals (Management and Safety) Rules has gone through several amendments and the latest draft amendment was published in Aug 2020. These Rules provide for Notification, Registration and Restrictions, or Prohibitions, as well as labelling and packaging requirements related to the use of substances, substances in mixtures, substances in articles and intermediates placed or intended to be placed in Indian Territory and introduce REACH-like registration requirements to certain >=1t/y priority substances. The rules are also known as "India REACH”.

Notification

All manufacturers or importers (or authorised pepresentatives acting on behalf of foreign entities) shall notify National Chemical Authority of all existing Substances that they have Placed in Indian Territory in quantities greater than 1 tonne per year. The notification is scheduled to start one year from the date of the enforcement of the rules, and end 180 days after their commencement. After this period, any substance not notified will be considered a new substance.

Information required includes baisic information about notifier, identity of the substance, its uses, the quantity of the substance.

New chemical substances shall also be notified before they are manufactured or imported to India. There are some substances exempt from notification and registration. They are listed in schedule IV.

Registration

All manufacturers, importers and authorised representatives (in the case of Foreign Manufacturers) that have placed or are intending to place in Indian Territory a substance listed in Schedule II in quantities greater than 1 tonne per annum must register such substance within one and half years from the date of inclusion of the substance in Schedule II.

Schedule II is a List of Priority Substances required to be registered. There are currently 750 hazardous substances on the list including benzene and methanol.

For the registration, a technical dossier consisting of physio-chemical data, tox , ecotox data and chemical safety report (for 10t/y substances only) needs to be submitted.

Note: non-isolated intermediates are exempt from registration. Data requirement for <1000t/y transported intermediate can be reduced.

Evaluation and Restriction

The Priority Substance Unit of the authority shall evaluate the available data to assess if a registered substance poses an unacceptable risk to human safety or the environment during various uses in India.If the risk is not acceptable, it may propose to restrict the use of such substance or prohibit such substance.

The list of restricted/prohibited substances is listed in Schedule VI. Currently only one substance, phosgene, is restricted.

Priority substance is defined as:

  1. any Substance which falls under any of the following Hazard Classifications of the eighth revision of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS Rev. 8): a. Carcinogenicity and/or Germ Cell Mutagenicity and/or Reproductive Toxicity and categorised as Category 1 or 2, or b. Specific Target Organ Toxicity (Repeated Exposure or Single Exposure) Category 1 or 2; or
  2. any Substance which fulfils the criteria of Persistent, Bio-accumulative and Toxic or very Persistent or very Bio-accumulative, as set out in Schedule I of these Rules; or
  3. any Substance listed in Schedule II.

Import of Priority Substances or Hazardous Chemicals

Upon completion of the relevant Registration and Notification requirements, an Importer of Substances listed in Schedule II or Hazardous Chemicals in India shall submit to the Concerned Authority, at least 15 days before Importation of such Substance in quantities greater than the lowest of 1 tonne, the quantity specified in column 3 of Schedule XII and column 3 of Schedule XI, information pertaining to:

  • (a) the name and address of the person receiving the consignment in India;
  • (b) the port of entry in India;
  • (c) mode of transport from the exporting country to India;
  • (d) name and the quantity of Priority Substances or Hazardous Chemicals being imported; and
  • (e) all relevant product safety information, including Safety Data Sheet

Labelling and Packing

A Manufacturer, Importer or Downstream User shall ensure that all Priority Substances, Hazardous Chemicals and Mixtures containing more than 10% (w/w) of any Priority Substance or Hazardous Chemicals comply with labelling and packging requirements. A Manufacturer, Importer or Downstream User shall ensure that all product identifiers, hazard statements and pictograms, signal words, and precautionary statements used in the labels of Priority Substances that they Place in Indian Territory shall be in accordance with the eighth revision of the United Nations Global Harmonised System of Classification (UN GHS).

Appended Schedules

The draft rules include several very important schedules and they are listed below.

  • Schedule I – PBT and vPvB Assessment Criteria
  • Schedule II – List of Priority Substances required to be Registered
  • Schedule III – Concerned Authorities
  • Schedule IV - Substances Exempt from Notification and Registration
  • Schedule V - Information to be provided for Notification
  • Schedule VI – Restricted or Prohibited Substances
  • Schedule VII - Contents of Technical Dossier
  • Schedule VIII - Format for Chemical Safety Report
  • Schedule IX – Safety Data Sheet 

References

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 Tags: Topics - IndiaREACH-like Regulation and Registration

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